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前哨淋巴结定位对 I 期子宫内膜癌患者报告的下肢肢体功能障碍的影响

2026年11月4日 更新者:NRG Oncology

前哨淋巴结定位对子宫内膜癌患者报告的下肢肢体功能障碍影响的 III 期试验

This phase III trial compares the effect of sentinel lymph node mapping to standard lymph node dissection in reducing the risk of swelling in the legs (lymphedema) in patients undergoing a hysterectomy for stage I endometrial cancer. Standard lymph node dissection removes lymph nodes around the uterus during a hysterectomy to look for spread of cancer from the uterus to nearby lymph nodes. Sentinel lymph node mapping uses a special dye and camera to look for cancer that may have spread to nearby lymph nodes. Comparing the results of the procedures may help doctors predict the risk of long-term swelling in the legs.

研究概览

详细说明

PRIMARY OBJECTIVES:

I. To compare the rates of lower extremity limb dysfunction (defined as a >= 4-point increase in Gynecologic Cancer Lymphedema Questionnaire [GCLQ] symptom score from baseline) in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of hysterectomy:

Ia. Sentinel lymph node mapping and excision followed by side-specific lymphadenectomy on sides without a sentinel lymph node (SLN) identified according to a National Comprehensive Cancer Network (NCCN) guidelines approved algorithm (Arm 1); Ib. Sentinel lymph node mapping and excision according to an NCCN Guidelines approved algorithm followed by bilateral pelvic +/- para-aortic lymphadenectomy (Arm 2).

SECONDARY OBJECTIVE:

I. To compare changes in lower extremity limb circumference in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of hysterectomy.

II. To validate the test characteristics of a SLN mapping algorithm including SLN detection rates, rate of perioperative complications, rate of identifying lymphatic metastases, and detection of micrometastases using pathologic ultra-staging.

EXPLORATORY OBJECTIVES:

I. To compare adjuvant therapy decisions in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of hysterectomy.

II. To explore the impact of patient characteristics (age, body mass index [BMI], race), extent of lymph node dissection, and adjuvant therapy decisions (radiation, chemotherapy) on the development of lower extremity limb dysfunction - as well as their interaction with lymph node assessment strategies.

III. To evaluate the cost-effectiveness of SLN mapping with or without completion of lymphadenectomy for endometrial cancer.

SAFETY OBJECTIVE:

I. To compare progression free and overall survival in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of hysterectomy.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients receive ICG dye via injection and undergo sentinel lymph node mapping and excision during standard minimally invasive hysterectomy. Lymph nodes around the uterus may be removed if the mapping and excision cannot be completed. Successful mapping requires no additional removal of lymph nodes.

ARM 2: Patients receive ICG dye via injection and undergo sentinel lymph node mapping and excision during standard minimally invasive hysterectomy. Additional lymph nodes around the uterus are removed per standard of care.

Patients in both arms also undergo imaging as clinically indicated and optional blood sample collection throughout the study.

After completion of study intervention, patients are followed every 3 months for one year and at 18 and 24 months.

研究类型

介入性

注册 (估计的)

428

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • District of Columbia
      • Washington D.C.、District of Columbia、美国、20037
        • 暂停
        • George Washington University Medical Center
    • Florida
      • Coral Gables、Florida、美国、33146
        • 招聘中
        • UM Sylvester Comprehensive Cancer Center at Coral Gables
        • 接触:
          • Site Public Contact
          • 电话号码:305-243-2647
        • 首席研究员:
          • Abdulrahman Sinno
      • Deerfield Beach、Florida、美国、33442
        • 招聘中
        • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
        • 接触:
          • Site Public Contact
          • 电话号码:305-243-2647
        • 首席研究员:
          • Abdulrahman Sinno
      • Doral、Florida、美国、33166
        • 招聘中
        • UM Sylvester Comprehensive Cancer Center at Doral
        • 首席研究员:
          • Abdulrahman Sinno
        • 接触:
      • Miami、Florida、美国、33136
        • 招聘中
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
        • 接触:
          • Site Public Contact
          • 电话号码:305-243-2647
        • 首席研究员:
          • Abdulrahman Sinno
      • Miami、Florida、美国、33176
        • 招聘中
        • UM Sylvester Comprehensive Cancer Center at Kendall
        • 接触:
          • Site Public Contact
          • 电话号码:305-243-2647
        • 首席研究员:
          • Abdulrahman Sinno
      • North Miami、Florida、美国、33181
        • 招聘中
        • University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
        • 首席研究员:
          • Abdulrahman Sinno
        • 接触:
      • Plantation、Florida、美国、33324
        • 招聘中
        • UM Sylvester Comprehensive Cancer Center at Plantation
        • 接触:
          • Site Public Contact
          • 电话号码:305-243-2647
        • 首席研究员:
          • Abdulrahman Sinno
    • Georgia
      • Augusta、Georgia、美国、30912
        • 招聘中
        • Augusta University Medical Center
        • 接触:
        • 首席研究员:
          • Robert V. Higgins
    • Illinois
      • Chicago、Illinois、美国、60611
        • 招聘中
        • Northwestern University
        • 接触:
        • 首席研究员:
          • Emily Hinchcliff
      • Warrenville、Illinois、美国、60555
        • 招聘中
        • Northwestern Medicine Cancer Center Warrenville
        • 接触:
        • 首席研究员:
          • Emily Hinchcliff
    • Indiana
      • Carmel、Indiana、美国、46032
        • 招聘中
        • IU Health North Hospital
        • 接触:
        • 首席研究员:
          • Jessica E. Parker
      • Indianapolis、Indiana、美国、46202
        • 招聘中
        • Indiana University/Melvin and Bren Simon Cancer Center
        • 接触:
        • 首席研究员:
          • Jessica E. Parker
    • Louisiana
      • Marrero、Louisiana、美国、70072
        • 招聘中
        • West Jefferson Medical Center
        • 接触:
        • 首席研究员:
          • Tara Castellano
      • Metairie、Louisiana、美国、70006
        • 招聘中
        • East Jefferson General Hospital
        • 接触:
        • 首席研究员:
          • Tara Castellano
      • Metairie、Louisiana、美国、70006
        • 招聘中
        • LSU Healthcare Network / Metairie Multi-Specialty Clinic
        • 接触:
        • 首席研究员:
          • Tara Castellano
      • New Orleans、Louisiana、美国、70112
        • 招聘中
        • University Medical Center New Orleans
        • 接触:
        • 首席研究员:
          • Tara Castellano
      • New Orleans、Louisiana、美国、70112
        • 招聘中
        • Louisiana State University Health Science Center
        • 接触:
        • 首席研究员:
          • Tara Castellano
    • Maryland
      • Baltimore、Maryland、美国、21201
        • 招聘中
        • University of Maryland/Greenebaum Cancer Center
        • 接触:
          • Site Public Contact
          • 电话号码:800-888-8823
        • 首席研究员:
          • Gautam G. Rao
      • Bel Air、Maryland、美国、21014
        • 招聘中
        • UM Upper Chesapeake Medical Center
        • 接触:
          • Site Public Contact
          • 电话号码:443-643-3010
        • 首席研究员:
          • Gautam G. Rao
    • Michigan
      • Detroit、Michigan、美国、48201
        • 招聘中
        • Wayne State University/Karmanos Cancer Institute
        • 首席研究员:
          • Robert T. Morris
        • 接触:
      • Farmington Hills、Michigan、美国、48334
        • 招聘中
        • Weisberg Cancer Treatment Center
        • 首席研究员:
          • Robert T. Morris
        • 接触:
      • Flint、Michigan、美国、48532
        • 招聘中
        • McLaren Cancer Institute-Flint
        • 首席研究员:
          • Robert T. Morris
        • 接触:
    • Minnesota
      • Edina、Minnesota、美国、55435
        • 招聘中
        • Fairview Southdale Hospital
        • 接触:
        • 首席研究员:
          • Britt K. Erickson
      • Maple Grove、Minnesota、美国、55369
        • 招聘中
        • Fairview Clinics and Surgery Center Maple Grove
        • 接触:
        • 首席研究员:
          • Britt K. Erickson
      • Maplewood、Minnesota、美国、55109
        • 招聘中
        • Saint John's Hospital - Healtheast
        • 接触:
        • 首席研究员:
          • Britt K. Erickson
      • Princeton、Minnesota、美国、55371
        • 招聘中
        • Fairview Northland Medical Center
        • 接触:
        • 首席研究员:
          • Britt K. Erickson
      • Saint Paul、Minnesota、美国、55101
        • 招聘中
        • Regions Hospital
        • 接触:
        • 首席研究员:
          • Britt K. Erickson
      • Wyoming、Minnesota、美国、55092
        • 招聘中
        • Fairview Lakes Medical Center
        • 接触:
        • 首席研究员:
          • Britt K. Erickson
    • Missouri
      • Springfield、Missouri、美国、65804
        • 招聘中
        • Mercy Hospital Springfield
        • 首席研究员:
          • Jay W. Carlson
        • 接触:
          • Site Public Contact
          • 电话号码:417-269-4520
    • Montana
      • Billings、Montana、美国、59101
        • 主动,不招人
        • Saint Vincent Healthcare
      • Billings、Montana、美国、59102
        • 主动,不招人
        • Saint Vincent Frontier Cancer Center
      • Billings、Montana、美国、59106
        • 主动,不招人
        • Intermountain Health West End Clinic
      • Butte、Montana、美国、59701
        • 主动,不招人
        • Saint James Community Hospital and Cancer Treatment Center
    • Nebraska
      • Kearney、Nebraska、美国、68845
        • 招聘中
        • Fred and Pamela Buffett Cancer Center - Kearney
        • 接触:
        • 首席研究员:
          • Kerry J. Rodabaugh
      • Omaha、Nebraska、美国、68198
        • 招聘中
        • University of Nebraska Medical Center
        • 接触:
        • 首席研究员:
          • Kerry J. Rodabaugh
      • Omaha、Nebraska、美国、68118
        • 招聘中
        • Nebraska Medicine-Village Pointe
        • 接触:
          • Site Public Contact
          • 电话号码:402-559-5600
        • 首席研究员:
          • Kerry J. Rodabaugh
      • Omaha、Nebraska、美国、68124
        • 主动,不招人
        • Alegent Health Bergan Mercy Medical Center
    • Nevada
      • Las Vegas、Nevada、美国、89106
        • 招聘中
        • Women's Cancer Center of Nevada
        • 首席研究员:
          • Nicola M. Spirtos
        • 接触:
          • Site Public Contact
          • 电话号码:702-851-4672
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73104
        • 招聘中
        • University of Oklahoma Health Sciences Center
        • 接触:
        • 首席研究员:
          • Christina Washington
    • Pennsylvania
      • Bryn Mawr、Pennsylvania、美国、19010
        • 暂停
        • Bryn Mawr Hospital
      • Paoli、Pennsylvania、美国、19301
        • 暂停
        • Paoli Memorial Hospital
      • Wynnewood、Pennsylvania、美国、19096
        • 暂停
        • Lankenau Medical Center
    • Rhode Island
      • Providence、Rhode Island、美国、02905
        • 招聘中
        • Women and Infants Hospital
        • 首席研究员:
          • Matthew T. Oliver
        • 接触:
          • Site Public Contact
          • 电话号码:401-274-1122
    • Texas
      • Dallas、Texas、美国、75390
        • 招聘中
        • UT Southwestern/Simmons Cancer Center-Dallas
        • 首席研究员:
          • Jayanthi S. Lea
        • 接触:
      • Dallas、Texas、美国、75235
        • 招聘中
        • Parkland Memorial Hospital
        • 首席研究员:
          • Jayanthi S. Lea
        • 接触:
      • Fort Worth、Texas、美国、76104
        • 招聘中
        • UT Southwestern/Simmons Cancer Center-Fort Worth
        • 首席研究员:
          • Jayanthi S. Lea
        • 接触:
      • Houston、Texas、美国、77030
        • 招聘中
        • Memorial Hermann Texas Medical Center
        • 接触:
          • Site Public Contact
          • 电话号码:713-792-3245
        • 首席研究员:
          • Joseph A. Lucci
      • Houston、Texas、美国、77030
        • 主动,不招人
        • Houston Methodist Hospital
      • Houston、Texas、美国、77070
        • 主动,不招人
        • Methodist Willowbrook Hospital
      • Houston、Texas、美国、77094
        • 主动,不招人
        • Houston Methodist West Hospital
      • Richardson、Texas、美国、75080
        • 招聘中
        • UT Southwestern Clinical Center at Richardson/Plano
        • 首席研究员:
          • Jayanthi S. Lea
        • 接触:
      • Sugar Land、Texas、美国、77479
        • 主动,不招人
        • Houston Methodist Sugar Land Hospital
      • The Woodlands、Texas、美国、77385
        • 主动,不招人
        • Houston Methodist The Woodlands Hospital
    • Virginia
      • Charlottesville、Virginia、美国、22908
      • Incheon、韩国、405-760
        • 招聘中
        • Gachon University Gil Hospital
        • 接触:
          • Site Public Contact
          • 电话号码:82-32-460-3213
        • 首席研究员:
          • Kwang-Beom Lee
      • Seoul、韩国、05505
        • 招聘中
        • Asan Medical Center
        • 接触:
        • 首席研究员:
          • Dae-Yeon Kim
      • Seoul、韩国、06273
        • 招聘中
        • Gangnam Severance Hospital
        • 首席研究员:
          • Jae-Hoon Kim
        • 接触:
          • Site Public Contact
          • 电话号码:82-2-2019-3600
      • Seoul、韩国、07985
        • 招聘中
        • Ewha Woman's University Mokdong Hospital
        • 接触:
          • Site Public Contact
          • 电话号码:82 2-2650-5114
        • 首席研究员:
          • Yun H. Kim
    • Gyeongsangnam-do
      • Seoul、Gyeongsangnam-do、韩国、51353
        • 暂停
        • Samsung Changwon Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Histologically proven diagnosis of endometrial cancer based on endometrial sampling with a plan to undergo laparoscopic or robotic hysterectomy and lymphatic assessment as part of primary management. Biopsy must be performed within 90 days prior to registration

  • Clinical stage I endometrial cancer based on the following diagnostic workup:

    • History/physical examination within 30 days prior to registration is reassuring for the absence of metastatic disease
  • Age >= 18 years

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2

  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information

  • Patients must speak English, Spanish, or Korean

Exclusion Criteria:

  • Patients whom the surgeon believes is not a candidate for pelvic lymphadenectomy due to medical comorbidities or other technical challenges (i.e. morbid obesity or prior surgery)

  • History of chemotherapy or immunotherapy for the treatment of endometrial cancer. Progestin-containing therapies such as megestrol, medroxyprogesterone, or levonorgestrel-containing intrauterine device (IUD) are acceptable

  • History of radiation to the pelvis, groin or lower extremities, or surgery to the pelvic lymph nodes or inguinal lymph nodes

  • Patients who are going to undergo another elective surgery during the same operative event as their hysterectomy (i.e., sacrocolpopexy, cholecystectomy)

  • Patients with severe, active co-morbidity defined as follows:

    • History of patient or provider identified lower extremity lymphedema
    • History of patient or provider identified chronic lower extremity swelling
    • History of lower extremity or pelvic deep venous thromboembolism within 90 days of registration
    • History of lower extremity cellulitis within 90 days of registration

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Arm 1 (sentinel lymph node mapping)

Patients receive ICG dye via injection and undergo sentinel lymph node mapping and excision during standard minimally invasive hysterectomy. Lymph nodes around the uterus may be removed if the mapping and excision cannot be completed. Successful mapping requires no additional removal of lymph nodes. Patients also undergo imaging as clinically indicated and optional blood sample collection throughout the study.

Undergo blood sample collection

其他名称:
  • 生物样本采集
  • 收集的生物样本
  • 标本采集
  • 样本收集

Ancillary studies

Undergo imaging

其他名称:
  • 医学影像
  • 诊断成像

Undergo sentinel lymph node excision

其他名称:
  • 手术活检
  • 活检,切除
  • Excision Biopsy

Given via injection

其他名称:
  • IC-绿
  • ICG解决方案

Undergo minimally invasive hysterectomy

其他名称:
  • 微创手术
  • 手术,微创

Undergo pelvic lymphadenectomy

其他名称:
  • 切除盆腔淋巴结
  • 盆腔淋巴结清扫术

Undergo sentinel lymph node mapping

其他名称:
  • 前哨淋巴结成像
实验性的:Arm 2 (sentinel lymph node mapping, pelvic lymphadenectomy)

Patients receive ICG dye via injection and undergo sentinel lymph node mapping and excision during standard minimally invasive hysterectomy. Additional lymph nodes around the uterus are removed per standard of care. Patients also undergo imaging as clinically indicated and optional blood sample collection throughout the study.

Undergo blood sample collection

其他名称:
  • 生物样本采集
  • 收集的生物样本
  • 标本采集
  • 样本收集

Ancillary studies

Undergo imaging

其他名称:
  • 医学影像
  • 诊断成像

Undergo sentinel lymph node excision

其他名称:
  • 手术活检
  • 活检,切除
  • Excision Biopsy

Given via injection

其他名称:
  • IC-绿
  • ICG解决方案

Undergo minimally invasive hysterectomy

其他名称:
  • 微创手术
  • 手术,微创

Undergo pelvic lymphadenectomy

其他名称:
  • 切除盆腔淋巴结
  • 盆腔淋巴结清扫术

Undergo sentinel lymph node mapping

其他名称:
  • 前哨淋巴结成像

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Incidence of patient-reported lower extremity limb dysfunction
大体时间:From 18 months post-hysterectomy after undergoing lymphatic assessment to 39 months

The primary endpoint is the incidence of patient-reported lower extremity limb dysfunction at 18 months post-hysterectomy after undergoing lymphatic assessment according to a National Comprehensive Cancer Network guideline-based sentinel lymph node (SLN) mapping algorithm with or without completion of lymphadenectomy. The primary endpoint will be assessed using the Gynecologic Cancer Lymphedema Questionnaire (GCLQ) questionnaire. Surveys will be performed at enrollment (pre-surgery) and at 3, 6, 9, 12, and 18 months post-surgery. Patient-reported lower extremity limb dysfunction will be defined as an increase in GCLQ symptom score of at least four (4) points from baseline at any time during the 18 months follow-up. The primary null hypothesis will be evaluated with an intent-to-treat chi-squared test, adjusted for stratification factors. Proportional hazards modeling will be used to generate a hazard ratio and 95% confidence limits of Arm 1 versus Arm 2.

From 18 months post-hysterectomy after undergoing lymphatic assessment to 39 months

次要结果测量

结果测量
措施说明
大体时间
The incidence of lymphedema by quantifiable lower extremity limb changes
大体时间:From enrollment and at 3, 6, 9, 12, and 18 months after surgery

Patients will undergo circumferential lower extremity limb measures at three locations along each leg. Change will be estimated as measurement at baseline subtracted from measurement at follow-up. This will be assessed in both legs separately.

From enrollment and at 3, 6, 9, 12, and 18 months after surgery
Rate of successful bilateral SLN identification
大体时间:At time of surgery

Will be assessed in both, and only as the time of surgery.

At time of surgery
Rate of successful identification of lymph node metastasis
大体时间:At time of surgery

Will be assessed in both, and only as the time of surgery. The rate of lymph node metastasis identification during surgery will be compared between groups, with either t-tests or chi-squared tests where appropriate.

At time of surgery
Rate of perioperative complications
大体时间:At time of surgery

Will be assessed in both arms separately, and only as the time of surgery. The rate of perioperative complications during surgery will be compared between groups, with either t-tests or chi-squared tests where appropriate.

At time of surgery

其他结果措施

结果测量
措施说明
大体时间
Adjuvant therapy decisions
大体时间:Up to 24 months

Adjuvant therapy decisions will be compared for patients according to study arm allocation after accounting for tumor characteristics, stage, and patient demographics to determine whether lymph node mapping strategies was associated with a difference in adjuvant therapy choice.

Up to 24 months
Patient characteristic, extent of lymph node dissection, and adjuvant therapy decisions
大体时间:Up to 24 months

Patient characteristics (age, body mass index, race), extent of lymph node dissection, and adjuvant therapy decisions (radiation, chemotherapy), will be collected to determine their impact as a covariate on the development of the primary endpoint (lower extremity limb dysfunction). Models adjusting for potential confounders will be fitted and analyzed.

Up to 24 months
Progression free survival
大体时间:The duration of time from study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed at 2 years after enrollment

This endpoint is not expected to be sufficiently powered for a definitive comparison and will therefore be treated as supportive evidence.

The duration of time from study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed at 2 years after enrollment
Overall survival
大体时间:Duration of time from study entry to time of death or the date of last contact, assessed at 2 years after enrollment

This endpoint is not expected to be sufficiently powered for a definitive comparison and will therefore be treated as supportive evidence.

Duration of time from study entry to time of death or the date of last contact, assessed at 2 years after enrollment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 首席研究员:Edward J Tanner、NRG Oncology

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年12月7日

初级完成 (估计的)

2029年3月31日

研究完成 (估计的)

2030年3月31日

研究注册日期

首次提交

2022年12月2日

首先提交符合 QC 标准的

2022年12月2日

首次发布 (实际的)

2022年12月12日

研究记录更新

最后更新发布 (实际的)

2026年11月6日

上次提交的符合 QC 标准的更新

2026年11月4日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • NRG-CC010
  • UG1CA189867 (美国 NIH 拨款/合同)
  • NCI-2022-05090 (注册表标识符:CTRP (Clinical Trial Reporting Program))
  • NRG-CC010 (其他标识符:CTEP)
  • NRG-CC010 (其他标识符:NRG Oncology)
  • NRG-CC010 (其他标识符:DCP)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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